MAG 5 PT ROLL-ON PAIN RELIEF COOLING
MAG 5 PT ROLL-ON PAIN RELIEF COOLING
Approved
Approval ID
31e4fa2c-3a98-d618-e063-6394a90aec1c
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 7, 2025
Manufacturers
FDA
RENU LABORATORIES, LLC
DUNS: 119451815
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76348-517
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 7, 2025
FDA Product Classification
INGREDIENTS (18)
MAGNESIUM OROTATEInactive
Code: GI96W46M5A
Classification: IACT
LOBELIA INFLATAInactive
Code: 9PP1T3TC5U
Classification: IACT
MAGNESIUM SULFATEInactive
Code: DE08037SAB
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
MAGNESIUM GLUCONATE ANHYDROUSInactive
Code: TH52F4317B
Classification: IACT
CANNABIS SATIVA SEED OILInactive
Code: 69VJ1LPN1S
Classification: IACT
CANNABIDIOLInactive
Code: 19GBJ60SN5
Classification: IACT
MENTHA PIPERITA (PEPPERMINT) OILInactive
Code: AV092KU4JH
Classification: IACT
MENTHOLActive
Quantity: 4.2 g in 84 g
Code: L7T10EIP3A
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
METHYLCELLULOSEInactive
Code: Z944H5SN0H
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
HAMAMELIS VIRGINIANA TOP WATERInactive
Code: NT00Y05A2V
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM MYRISTATEInactive
Code: Z1917F0578
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT